Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001865-11 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the efficacy of TV-44749 in adult participants with schizophrenia.
A key secondary objective is to further evaluate the efficacy of TV-44749 based on additional parameters in adult participants with schizophrenia.
A secondary objective is to evaluate the safety and tolerability of TV-44749 in adult participants with schizophrenia
Another secondary objective of this study is to evaluate the efficacy of TV-44749 from baseline to endpoint in Period 1 in adult participants with schizophrenia.
Total study duration is up to 61 weeks, and treatment duration is up to 56 weeks, with weekly visits during the first 8 weeks and then monthly in-clinic visits with weekly calls during the remainder of the treatment period.
Participants with exacerbation of schizophrenia may be included. The study will be composed of 2 periods: Period 1 (the double-blind, placebo-controlled, efficacy and safety period) and Period 2 (open-label long term safety period). For each participant, the duration of Period 1 will be 8 weeks, and the duration of Period 2 will be up to 48 weeks. In Period 1, participants will be randomized to one of 3 TV-44749 treatment groups or a placebo group in a 1:1:1:1 ratio. All participants will be randomized again to one of the TV44749 treatment groups in a 1:1:1 ratio for Period 2. The end-of-treatment and follow-up visits will be at 4 and 8 weeks after the last dose of investigational medicinal product administration, respectively.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-blind Period: Placebo | Placebo Comparator | Participants will receive placebo matched to TV-44749 subcutaneously (SC) once monthly over 8 weeks in double-blind period. |
|
| Double-blind Period: TV-44749 318 mg | Experimental | Participants will receive TV-44749 extended-release injectable suspension at a dose of 318 milligrams (mg) SC once monthly over 8 weeks in double-blind period. |
|
| Double-blind Period: TV-44749 425 mg | Experimental | Participants will receive TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
|
| Double-blind Period: TV-44749 531 mg | Experimental | Participants will receive TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
| Open-label Period: Placebo to TV-44749 318 mg | Experimental | Participants who receive placebo during the double-blind period, will receive TV-44749 extended-release injectable suspension at a dose of 318 mg SC once monthly for up to 48 weeks in open-label period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TV-44749 | Drug | In Period 1, 2 monthly injections. In Period 2, up to 12 monthly injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Double-blind Period: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 8 | The PANSS is a 30-item scale used to evaluate positive and negative symptoms of schizophrenia. The PANSS was used to identify the presence and severity of psychopathology symptoms, the relationship of these symptoms to one another, and the global psychopathology. Each item was scored on a 7-point scale ranging from 1 (absent) to 7 (extreme). The positive symptom scale includes 7 items with a maximum score of 49; the negative symptom scale includes 7 items with a maximum score of 49; and the general psychopathology scale includes 16 items with a maximum score of 112. The total score was the sum of 30-item scale, ranging from 30 (absent) to 210 (extreme), with a higher score indicating greater severity of symptoms. Least square (LS) mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PANSS total score at baseline as covariates. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Double-blind Period: Change in Clinical Global Impression-Severity (CGI-S) Scale Score From Baseline to Week 8 | The CGI-S is a 7-point scale that assess the participant's current severity of illness on a scale of 1 to 7, where 1=normal/not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and CGI-S score at baseline as covariates. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 15460 | Bentonville | Arkansas | 72712 | United States | ||
| Teva Investigational Site 15465 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41632432 | Derived | Cherniakov I, Wagner AM, Eshet R, Tiver R, Bibi D, Perlstein I, Kalmanczhelyi A, Sharon N, Cohen G, Ferderber K, Roberts J, Elgart A, Gutman D, Rabinovich-Guilatt L. Safety, Tolerability, and Pharmacokinetics of Subcutaneous Extended-Release Injectable Olanzapine in Patients with Schizophrenia and Schizoaffective Disorder. Clin Drug Investig. 2026 Mar;46(3):307-320. doi: 10.1007/s40261-025-01507-x. Epub 2026 Feb 3. | |
| 41496255 |
Not provided
Not provided
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Not provided
Not provided
Not provided
Not provided
Per planned analysis, the safety analysis was performed separately for Period 1 and for the integrated trial period. Integrated trial period included all participants who received 1 of the 3 TV-44749 treatments in Period 1 and all randomized participants to Period 2 who received at least 1 dose of TV-44749.
The study comprised 2 periods: Period 1 (double-blind, placebo-controlled, efficacy and safety period [acute treatment phase]) and Period 2 (open-label safety period [long-term safety phase]).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to TV-44749 subcutaneously (SC) once monthly over 8 weeks in double-blind period. |
| FG001 | TV-44749 318 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 318 milligrams (mg) SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Double-blind Period (8 Weeks) |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2024 | Dec 17, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Open-label Period: Placebo to TV-44749 425 mg | Experimental | Participants who receive placebo during the double-blind period, will receive TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly for up to 48 weeks in open-label period. |
|
| Open-label Period: Placebo to TV-44749 531 mg | Experimental | Participants who receive placebo during the double-blind period, will receive TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly for up to 48 weeks in open-label period. |
|
|
| Placebo | Drug | In Period 1, 2 monthly injections (Period 1 only) |
|
| Baseline, Week 8 |
| Double-blind Period: Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 8 | The PSP is a clinician-rated instrument that measures personal and social functioning in participants with schizophrenia. The PSP is a 100-point single-item rating scale, divided into 10 equal intervals, where 0 (grossly impaired functioning) to 100 (excellent functioning). The score was based on the assessment of participant's functioning in 4 categories: 1) socially useful activities, including work and study; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviors. Higher scores represented better personal and social functioning, with ratings from 91 to 100 indicating more than adequate functioning, while scores under 30 indicating poor functioning that required intensive supervision. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PSP score at baseline as covariates. | Baseline, Week 8 |
| Double-blind Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section. | Baseline up to Week 8 |
| Integrated Study Period: Number of Participants With AEs and SAEs | An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section. | Baseline up to Week 60 |
| Double-blind Period: Change in PANSS Total Score From Baseline to Weeks 1, 2, and 4 | The PANSS is a 30-item scale used to evaluate positive and negative symptoms of schizophrenia. The PANSS was used to identify the presence and severity of psychopathology symptoms, the relationship of these symptoms to one another, and the global psychopathology. Each item was scored on a 7-point scale ranging from 1 (absent) to 7 (extreme). The positive symptom scale includes 7 items with a maximum score of 49; the negative symptom scale includes 7 items with a maximum score of 49; and the general psychopathology scale includes 16 items with a maximum score of 112. The total score was the sum of 30-item scale, ranging from 30 (absent) to 210 (extreme), with a higher score indicating greater severity of symptoms. Least square (LS) mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PANSS total score at baseline as covariates. | Baseline, Weeks 1, 2, and 4 |
| Double-blind Period: Clinical Global Impression-Improvement (CGI-I) Scale Score at Weeks 4 and 8 | The CGI-I is a 7-point scale that permits a global evaluation of the participant's overall improvement in symptoms on a scale of 1 to 7, where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and CGI-I score at baseline as covariates. | Weeks 4 and 8 |
| Double-blind Period: Change in CGI-S Scale Score From Baseline to Weeks 1, 2, and 4 | The CGI-S is a 7-point scale that assess the participant's current severity of illness on a scale of 1 to 7, where 1=normal/not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and CGI-S score at baseline as covariates. | Baseline, Weeks 1, 2, and 4 |
| Double-blind Period: Patient Global Impression-Improvement (PGI-I) Scale Score at Weeks 2, 4, and 8 | The PGI-I scale is a 1-item participant-rated instrument that measures improvement of the participant's disease. The participant rated the perceived change in his/her condition in response to therapy on a scale of 1 to 7, where 1=very much better, 2=much better, 3=a little better, 4=no change, 5=a little worse, 6=much worse, 7=very much worse. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PGI-I score at baseline as covariates. | Weeks 2, 4, and 8 |
| Double-blind Period: Change in Schizophrenia Quality of Life Scale (SQLS) Total Score From Baseline to Weeks 4 and 8 | The SQLS Revision 4 was administered to capture quality of life. The 33-item measure yields subscales pertaining to psychosocial (20 items) and cognition/vitality factors (13 items). Each item was scored on a 5-point scale (1 - never, 2 - rarely, 3 - sometimes, 4 - often, 5 - always). Individual domain and total scores were standardized by scoring algorithm from 0 (best health status) to 100 (worst health status) scale, with higher scores indicating comparatively lower quality of life. | Baseline, Weeks 4 and 8 |
| Double-blind Period: Change in PSP Score From Baseline to Week 4 | The PSP is a clinician-rated instrument that measures personal and social functioning in participants with schizophrenia. The PSP is a 100-point single-item rating scale, divided into 10 equal intervals, where 0 (grossly impaired functioning) to 100 (excellent functioning). The score was based on the assessment of participant's functioning in 4 categories: 1) socially useful activities, including work and study; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviors. Higher scores represented better personal and social functioning, with ratings from 91 to 100 indicating more than adequate functioning, while scores under 30 indicating functioning so poor that intensive supervision was required. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PSP score at baseline as covariates. | Baseline, Week 4 |
| Double-blind Period: Number of Participants Receiving At Least 1 Concomitant Medication | Concomitant medications included all medications taken while the participant was treated with the study drug. Any concomitant medication received by the participant for AEs was recorded on the case report form (CRF). Concomitant medications included: zolpidem, zopiclone, zaleplon, or diphenhydramine for insomnia; benztropine, trihexyphenidyl, or diphenhydramine for parkinsonian symptoms; propranolol and benzodiazepines for akathisia; lorazepam on an as-needed basis for indications other than akathisia (for example, anxiety); and antihistamine and anticholinergic drugs for agitation and insomnia. | Baseline up to Week 8 |
| Integrated Study Period: Number of Participants Receiving At Least 1 Concomitant Medication | Concomitant medications included all medications taken while the participant was treated with the study drug. Any concomitant medication received by the participant for AEs was recorded on the CRF. Concomitant medications included: zolpidem, zopiclone, zaleplon, or diphenhydramine for insomnia; benztropine, trihexyphenidyl, or diphenhydramine for parkinsonian symptoms; propranolol and benzodiazepines for akathisia; lorazepam on an as-needed basis for indications other than akathisia (for example, anxiety); and antihistamine and anticholinergic drugs for agitation and insomnia. | Baseline up to Week 60 |
| Double-blind Period: Change From Baseline to Week 8 in Abnormal Involuntary Movement Scale (AIMS) Total Score | The AIMS is a 14-item scale that includes assessments of orofacial movements, extremity and truncal dyskinesia, examiner's judgment of global severity, subjective measures of awareness of movements and distress, and a yes/no assessment of problems concerning teeth and/or dentures. AIMS total score was calculated as a sum of items 1 through 7. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated from 0 (none) to 4 (severe) The AIMS total score for Items 1-7 ranged from 0 (no dyskinesia) to 28 (severe dyskinesia) with a higher score indicating greater severity of the condition. | Baseline, Week 8 |
| Integrated Study Period: Change From Baseline to Week 60 in AIMS Total Score | The AIMS is a 14-item scale that includes assessments of orofacial movements, extremity and truncal dyskinesia, examiner's judgment of global severity, subjective measures of awareness of movements and distress, and a yes/no assessment of problems concerning teeth and/or dentures. AIMS total score was calculated as a sum of items 1 through 7. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated from 0 (none) to 4 (severe) The AIMS total score for Items 1-7 ranged from 0 (no dyskinesia) to 28 (severe dyskinesia) with a higher score indicating greater severity of the condition. | Baseline, Week 60 |
| Double-blind Period: Change From Baseline to Week 8 in Simpson-Angus Scale (SAS) Mean Score | The SAS is a 10-item instrument for the assessment of neuroleptic-induced parkinsonism. The items on the scale include measurements of hypokinesia, rigidity, glabellar reflex, tremor, and salivation. Each item was rated on a 5-point scale (0 [normal] to 4 [severe]). The mean score was calculated by adding the individual item scores and dividing by 10, ranging from 0 (normal) to 4 (severe) with a higher score indicating greater severity of symptoms. | Baseline, Week 8 |
| Integrated Study Period: Change From Baseline to Week 60 in SAS Mean Score | The SAS is a 10-item instrument for the assessment of neuroleptic-induced parkinsonism. The items on the scale include measurements of hypokinesia, rigidity, glabellar reflex, tremor, and salivation. Each item was rated on a 5-point scale (0 [normal] to 4 [severe]). The mean score was calculated by adding the individual item scores and dividing by 10, ranging from 0 (normal) to 4 (severe) with a higher score indicating greater severity of symptoms. | Baseline, Week 60 |
| Double-blind Period: Change From Baseline to Week 8 in Barnes Akathisia Rating Scale (BARS) Total Score | The BARS is an instrument that assesses the severity of drug-induced akathisia. The BARS included 3 items for rating objective restless movements, subjective restlessness, and any subjective distress associated with akathisia that were scored on a 4-point scale of 0 (normal) to 3 (most severe) and summed up yielding a total score ranging from 0 (normal) to 9 (most severe). Higher scores indicated greater severity of akathisia. | Baseline, Week 8 |
| Integrated Study Period: Change From Baseline to Week 60 in BARS Total Score | The BARS is an instrument that assesses the severity of drug-induced akathisia. The BARS included 3 items for rating objective restless movements, subjective restlessness, and any subjective distress associated with akathisia that were scored on a 4-point scale of 0 (normal) to 3 (most severe) and summed up yielding a total score ranging from 0 (normal) to 9 (most severe). Higher scores indicated greater severity of akathisia. | Baseline, Week 60 |
| Double-blind Period: Number of Participants With Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent. | Baseline up to Week 8 |
| Integrated Study Period: Number of Participants With Any Suicidal Ideation or Suicidal Behavior According to the C-SSRS | The C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent. | Baseline up to Week 60 |
| Double-blind Period: Change From Baseline to Week 8 in Calgary Depression Scale for Schizophrenia (CDSS) Score | The CDSS is specifically designed to assess the level of depression separate from the positive, negative, and extrapyramidal symptoms in schizophrenia. This clinician-administered instrument consisted of 9 items, each rated on a 4-point scale from 0 (absent) to 3 (severe) that are added together to form the CDSS depression total score for the participant ranging from 0 (absent) to 27 (severe) with higher scores indicating a higher severity of depression. | Baseline, Week 8 |
| Integrated Study Period: Change From Baseline to Week 60 in CDSS Score | The CDSS is specifically designed to assess the level of depression separate from the positive, negative, and extrapyramidal symptoms in schizophrenia. This clinician-administered instrument consisted of 9 items, each rated on a 4-point scale from 0 (absent) to 3 (severe) that are added together to form the CDSS depression total score for the participant ranging from 0 (absent) to 27 (severe) with higher scores indicating a higher severity of depression. | Baseline, Week 60 |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Teva Investigational Site 15453 | Rogers | Arkansas | 72758 | United States |
| Teva Investigational Site 15470 | Anaheim | California | 92805 | United States |
| Teva Investigational Site 15459 | Bellflower | California | 90706 | United States |
| Teva Investigational Site 15490 | Garden Grove | California | 92845 | United States |
| Teva Investigational Site 15474 | La Habra | California | 90631 | United States |
| Teva Investigational Site 15481 | Lemon Grove | California | 91945 | United States |
| Teva Investigational Site 15491 | Long Beach | California | 90807 | United States |
| Teva Investigational Site 15497 | Los Angeles | California | 90015 | United States |
| Teva Investigational Site 15482 | Los Angeles | California | 91436 | United States |
| Teva Investigational Site 15450 | Orange | California | 92868 | United States |
| Teva Investigational Site 15455 | Pico Rivera | California | 90660 | United States |
| Teva Investigational Site 15471 | Riverside | California | 92506 | United States |
| Teva Investigational Site 15444 | San Diego | California | 92123 | United States |
| Teva Investigational Site 15449 | Santee | California | 92071 | United States |
| Teva Investigational Site 15461 | Sherman Oaks | California | 91403 | United States |
| Teva Investigational Site 15483 | Torrance | California | 90504 | United States |
| Teva Investigational Site 15457 | Hialeah | Florida | 33016 | United States |
| Teva Investigational Site 15488 | Hollywood | Florida | 33021 | United States |
| Teva Investigational Site 15498 | Hollywood | Florida | 33021 | United States |
| Teva Investigational Site 15458 | Hollywood | Florida | 33024 | United States |
| Teva Investigational Site 15489 | Homestead | Florida | 33030 | United States |
| Teva Investigational Site 15452 | Miami | Florida | 33122 | United States |
| Teva Investigational Site 15495 | Miami | Florida | 33122 | United States |
| Teva Investigational Site 15446 | Miami | Florida | 33155 | United States |
| Teva Investigational Site 15456 | Miami | Florida | 33155 | United States |
| Teva Investigational Site 15479 | Miami | Florida | 33155 | United States |
| Teva Investigational Site 15462 | Miami | Florida | 33173 | United States |
| Teva Investigational Site 15496 | Miami | Florida | 33176-2302 | United States |
| Teva Investigational Site 15494 | Miami Lakes | Florida | 33014 | United States |
| Teva Investigational Site 15467 | Miami Lakes | Florida | 33016 | United States |
| Teva Investigational Site 15473 | Miami Lakes | Florida | 33016 | United States |
| Teva Investigational Site 15484 | Miami Springs | Florida | 33166 | United States |
| Teva Investigational Site 15477 | West Palm Beach | Florida | 33407 | United States |
| Teva Investigational Site 15468 | Atlanta | Georgia | 30331 | United States |
| Teva Investigational Site 15469 | Decatur | Georgia | 30030 | United States |
| Teva Investigational Site 15500 | Peachtree Corners | Georgia | 30071 | United States |
| Teva Investigational Site 15485 | Chicago | Illinois | 60640 | United States |
| Teva Investigational Site 15480 | Chicago | Illinois | 60641 | United States |
| Teva Investigational Site 15447 | Shreveport | Louisiana | 71101 | United States |
| Teva Investigational Site 15442 | Gaithersburg | Maryland | 20877 | United States |
| Teva Investigational Site 15466 | Flowood | Mississippi | 39232 | United States |
| Teva Investigational Site 15487 | St Louis | Missouri | 63141 | United States |
| Teva Investigational Site 15451 | Marlton | New Jersey | 08053 | United States |
| Teva Investigational Site 15441 | Charlotte | North Carolina | 28211 | United States |
| Teva Investigational Site 15454 | Dayton | Ohio | 45417 | United States |
| Teva Investigational Site 15472 | North Canton | Ohio | 44720 | United States |
| Teva Investigational Site 15478 | Oklahoma City | Oklahoma | 73112 | United States |
| Teva Investigational Site 15448 | Austin | Texas | 78754 | United States |
| Teva Investigational Site 15486 | DeSoto | Texas | 75115 | United States |
| Teva Investigational Site 15464 | Irving | Texas | 75062 | United States |
| Teva Investigational Site 15443 | Richardson | Texas | 75080 | United States |
| Teva Investigational Site 59210 | Burgas | 8000 | Bulgaria |
| Teva Investigational Site 59203 | Kazanlak | 6100 | Bulgaria |
| Teva Investigational Site 59208 | Lovech | 5500 | Bulgaria |
| Teva Investigational Site 59214 | Pleven | 5800 | Bulgaria |
| Teva Investigational Site 59207 | Plovdiv | 4000 | Bulgaria |
| Teva Investigational Site 59215 | Razgrad | 7200 | Bulgaria |
| Teva Investigational Site 59202 | Rousse | 7003 | Bulgaria |
| Teva Investigational Site 59211 | Sliven | 8800 | Bulgaria |
| Teva Investigational Site 59205 | Sofia | 1202 | Bulgaria |
| Teva Investigational Site 59212 | Sofia | 1377 | Bulgaria |
| Teva Investigational Site 59209 | Veliko Tarnovo | 5000 | Bulgaria |
| Teva Investigational Site 59206 | Vratsa | 3000 | Bulgaria |
| Teva Investigational Site 88052 | Beijing | 100088 | China |
| Teva Investigational Site 88044 | Hangzhou | 310012 | China |
| Teva Investigational Site 88060 | Hefei | 230022 | China |
| Teva Investigational Site 88055 | Jining Shi | 272051 | China |
| Teva Investigational Site 88068 | Nanchang | 330046 | China |
| Teva Investigational Site 88053 | Shanghai | 200030 | China |
| Teva Investigational Site 88054 | Tianjin | 300222 | China |
| Teva Investigational Site 88071 | Wuhan | 430030 | China |
| Teva Investigational Site 88072 | Xinxiang | 453003 | China |
| Teva Investigational Site 88064 | Zhumadian | 463002 | China |
| Teva Investigational Site 52124 | Bucharest | 041914 | Romania |
| Teva Investigational Site 52127 | Bucharest | 10825 | Romania |
| Teva Investigational Site 52123 | Iași | 700282 | Romania |
| Teva Investigational Site 52126 | Iași | 700282 | Romania |
| Teva Investigational Site 82058 | Adapazarı | 54290 | Turkey (Türkiye) |
| Teva Investigational Site 82059 | Ankara | 6010 | Turkey (Türkiye) |
| Teva Investigational Site 82057 | Bursa | 16059 | Turkey (Türkiye) |
| Derived |
| Perlstein I, Cherniakov I, Elgart A, Gomeni R, Gutman D, Merenlender Wagner A, Singh R. Population Pharmacokinetic Model-Based Dose Selection of Extended-Release Injectable Olanzapine (TV-44749) for Subcutaneous Use in Phase 3 Clinical Trial in Adults with Schizophrenia. J Clin Pharmacol. 2026 Jan;66(1):e70144. doi: 10.1002/jcph.70144. |
| FG002 | TV-44749 425 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
| FG003 | TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
| FG004 | Placebo to TV-44749 318 mg | Participants who received placebo during the double-blind period, received TV-44749 extended-release injectable suspension at a dose of 318 mg SC once monthly for up to 48 weeks in open-label period. |
| FG005 | Placebo to TV-44749 425 mg | Participants who received placebo during the double-blind period, received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly for up to 48 weeks in open-label period. |
| FG006 | Placebo to TV-44749 531 mg | Participants who received placebo during the double-blind period, received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly for up to 48 weeks in open-label period. |
|
| Received at Least 1 Dose of Study Drug |
|
| Safety Analysis Set for Period 1 | All randomized participants who received at least 1 dose of TV-44749 or placebo. Participants were included in the treatment group corresponding to what they actually received. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-label Period (48 Weeks) |
|
|
The Full Analysis Set included all participants randomized to study arms in Period 1 regardless of the actual treatment the participants received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to TV-44749 SC once monthly over 8 weeks in double-blind period. |
| BG001 | TV-44749 318 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 318 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
| BG002 | TV-44749 425 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
| BG003 | TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Double-blind Period: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 8 | The PANSS is a 30-item scale used to evaluate positive and negative symptoms of schizophrenia. The PANSS was used to identify the presence and severity of psychopathology symptoms, the relationship of these symptoms to one another, and the global psychopathology. Each item was scored on a 7-point scale ranging from 1 (absent) to 7 (extreme). The positive symptom scale includes 7 items with a maximum score of 49; the negative symptom scale includes 7 items with a maximum score of 49; and the general psychopathology scale includes 16 items with a maximum score of 112. The total score was the sum of 30-item scale, ranging from 30 (absent) to 210 (extreme), with a higher score indicating greater severity of symptoms. Least square (LS) mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PANSS total score at baseline as covariates. | Full Analysis Set included all participants randomized to study arms in Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 8 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Change in Clinical Global Impression-Severity (CGI-S) Scale Score From Baseline to Week 8 | The CGI-S is a 7-point scale that assess the participant's current severity of illness on a scale of 1 to 7, where 1=normal/not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and CGI-S score at baseline as covariates. | Full Analysis Set included all participants randomized to study arms in Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 8 | The PSP is a clinician-rated instrument that measures personal and social functioning in participants with schizophrenia. The PSP is a 100-point single-item rating scale, divided into 10 equal intervals, where 0 (grossly impaired functioning) to 100 (excellent functioning). The score was based on the assessment of participant's functioning in 4 categories: 1) socially useful activities, including work and study; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviors. Higher scores represented better personal and social functioning, with ratings from 91 to 100 indicating more than adequate functioning, while scores under 30 indicating poor functioning that required intensive supervision. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PSP score at baseline as covariates. | Full Analysis Set included all participants randomized to study arms in Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section. | Safety Analysis Set for Period 1 included all randomized participants who received at least 1 dose of TV-44749 or placebo. Participants were included in the treatment group corresponding to what they actually received. | Posted | Count of Participants | Participants | Baseline up to Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Integrated Study Period: Number of Participants With AEs and SAEs | An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section. | Safety Analysis Set for integrated study period included all participants in the safety analysis set of period 1 that received 1 of the 3 TV-44749 treatments groups and all randomized participants to Period 2 who received at least 1 dose of TV-44749. Participants were included in their randomized treatment groups regardless of the actual treatment received. | Posted | Count of Participants | Participants | Baseline up to Week 60 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Change in PANSS Total Score From Baseline to Weeks 1, 2, and 4 | The PANSS is a 30-item scale used to evaluate positive and negative symptoms of schizophrenia. The PANSS was used to identify the presence and severity of psychopathology symptoms, the relationship of these symptoms to one another, and the global psychopathology. Each item was scored on a 7-point scale ranging from 1 (absent) to 7 (extreme). The positive symptom scale includes 7 items with a maximum score of 49; the negative symptom scale includes 7 items with a maximum score of 49; and the general psychopathology scale includes 16 items with a maximum score of 112. The total score was the sum of 30-item scale, ranging from 30 (absent) to 210 (extreme), with a higher score indicating greater severity of symptoms. Least square (LS) mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PANSS total score at baseline as covariates. | Full Analysis Set included all participants randomized to study arms in Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Weeks 1, 2, and 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Clinical Global Impression-Improvement (CGI-I) Scale Score at Weeks 4 and 8 | The CGI-I is a 7-point scale that permits a global evaluation of the participant's overall improvement in symptoms on a scale of 1 to 7, where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and CGI-I score at baseline as covariates. | Full Analysis Set included all participants randomized to study arms in Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 4 and 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Change in CGI-S Scale Score From Baseline to Weeks 1, 2, and 4 | The CGI-S is a 7-point scale that assess the participant's current severity of illness on a scale of 1 to 7, where 1=normal/not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and CGI-S score at baseline as covariates. | Full Analysis Set included all participants randomized to Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Weeks 1, 2, and 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Patient Global Impression-Improvement (PGI-I) Scale Score at Weeks 2, 4, and 8 | The PGI-I scale is a 1-item participant-rated instrument that measures improvement of the participant's disease. The participant rated the perceived change in his/her condition in response to therapy on a scale of 1 to 7, where 1=very much better, 2=much better, 3=a little better, 4=no change, 5=a little worse, 6=much worse, 7=very much worse. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PGI-I score at baseline as covariates. | Full Analysis Set included all participants randomized to Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 2, 4, and 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Change in Schizophrenia Quality of Life Scale (SQLS) Total Score From Baseline to Weeks 4 and 8 | The SQLS Revision 4 was administered to capture quality of life. The 33-item measure yields subscales pertaining to psychosocial (20 items) and cognition/vitality factors (13 items). Each item was scored on a 5-point scale (1 - never, 2 - rarely, 3 - sometimes, 4 - often, 5 - always). Individual domain and total scores were standardized by scoring algorithm from 0 (best health status) to 100 (worst health status) scale, with higher scores indicating comparatively lower quality of life. | Full Analysis Set included all participants randomized to Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Weeks 4 and 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Change in PSP Score From Baseline to Week 4 | The PSP is a clinician-rated instrument that measures personal and social functioning in participants with schizophrenia. The PSP is a 100-point single-item rating scale, divided into 10 equal intervals, where 0 (grossly impaired functioning) to 100 (excellent functioning). The score was based on the assessment of participant's functioning in 4 categories: 1) socially useful activities, including work and study; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviors. Higher scores represented better personal and social functioning, with ratings from 91 to 100 indicating more than adequate functioning, while scores under 30 indicating functioning so poor that intensive supervision was required. LS mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PSP score at baseline as covariates. | Full Analysis Set included all participants randomized to Period 1 regardless of the actual treatment the participants received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Number of Participants Receiving At Least 1 Concomitant Medication | Concomitant medications included all medications taken while the participant was treated with the study drug. Any concomitant medication received by the participant for AEs was recorded on the case report form (CRF). Concomitant medications included: zolpidem, zopiclone, zaleplon, or diphenhydramine for insomnia; benztropine, trihexyphenidyl, or diphenhydramine for parkinsonian symptoms; propranolol and benzodiazepines for akathisia; lorazepam on an as-needed basis for indications other than akathisia (for example, anxiety); and antihistamine and anticholinergic drugs for agitation and insomnia. | Safety Analysis Set for Period 1 included all randomized participants who received at least 1 dose of TV-44749 or placebo. Participants were included in the treatment group corresponding to what they actually received. | Posted | Count of Participants | Participants | Baseline up to Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Integrated Study Period: Number of Participants Receiving At Least 1 Concomitant Medication | Concomitant medications included all medications taken while the participant was treated with the study drug. Any concomitant medication received by the participant for AEs was recorded on the CRF. Concomitant medications included: zolpidem, zopiclone, zaleplon, or diphenhydramine for insomnia; benztropine, trihexyphenidyl, or diphenhydramine for parkinsonian symptoms; propranolol and benzodiazepines for akathisia; lorazepam on an as-needed basis for indications other than akathisia (for example, anxiety); and antihistamine and anticholinergic drugs for agitation and insomnia. | Safety Analysis Set for integrated study period included all participants in the safety analysis set of period 1 that received 1 of the 3 TV-44749 treatments groups and all randomized participants to Period 2 who received at least 1 dose of TV-44749. Participants were included in their randomized treatment groups regardless of the actual treatment received. | Posted | Count of Participants | Participants | Baseline up to Week 60 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Change From Baseline to Week 8 in Abnormal Involuntary Movement Scale (AIMS) Total Score | The AIMS is a 14-item scale that includes assessments of orofacial movements, extremity and truncal dyskinesia, examiner's judgment of global severity, subjective measures of awareness of movements and distress, and a yes/no assessment of problems concerning teeth and/or dentures. AIMS total score was calculated as a sum of items 1 through 7. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated from 0 (none) to 4 (severe) The AIMS total score for Items 1-7 ranged from 0 (no dyskinesia) to 28 (severe dyskinesia) with a higher score indicating greater severity of the condition. | Safety Analysis Set for Period 1 included all randomized participants who received at least 1 dose of TV-44749 or placebo. Participants were included in the treatment group corresponding to what they actually received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Integrated Study Period: Change From Baseline to Week 60 in AIMS Total Score | The AIMS is a 14-item scale that includes assessments of orofacial movements, extremity and truncal dyskinesia, examiner's judgment of global severity, subjective measures of awareness of movements and distress, and a yes/no assessment of problems concerning teeth and/or dentures. AIMS total score was calculated as a sum of items 1 through 7. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated from 0 (none) to 4 (severe) The AIMS total score for Items 1-7 ranged from 0 (no dyskinesia) to 28 (severe dyskinesia) with a higher score indicating greater severity of the condition. | Safety Analysis Set for integrated study period included all participants in the safety analysis set of period 1 that received 1 of the 3 TV-44749 treatments groups and all randomized participants to Period 2 who received at least 1 dose of TV-44749. Participants were included in their randomized treatment groups regardless of the actual treatment received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 60 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Change From Baseline to Week 8 in Simpson-Angus Scale (SAS) Mean Score | The SAS is a 10-item instrument for the assessment of neuroleptic-induced parkinsonism. The items on the scale include measurements of hypokinesia, rigidity, glabellar reflex, tremor, and salivation. Each item was rated on a 5-point scale (0 [normal] to 4 [severe]). The mean score was calculated by adding the individual item scores and dividing by 10, ranging from 0 (normal) to 4 (severe) with a higher score indicating greater severity of symptoms. | Safety Analysis Set for Period 1 included all randomized participants who received at least 1 dose of TV-44749 or placebo. Participants were included in the treatment group corresponding to what they actually received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Integrated Study Period: Change From Baseline to Week 60 in SAS Mean Score | The SAS is a 10-item instrument for the assessment of neuroleptic-induced parkinsonism. The items on the scale include measurements of hypokinesia, rigidity, glabellar reflex, tremor, and salivation. Each item was rated on a 5-point scale (0 [normal] to 4 [severe]). The mean score was calculated by adding the individual item scores and dividing by 10, ranging from 0 (normal) to 4 (severe) with a higher score indicating greater severity of symptoms. | Safety Analysis Set for integrated study period included all participants in the safety analysis set of period 1 that received 1 of the 3 TV-44749 treatments groups and all randomized participants to Period 2 who received at least 1 dose of TV-44749. Participants were included in their randomized treatment groups regardless of the actual treatment received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 60 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Change From Baseline to Week 8 in Barnes Akathisia Rating Scale (BARS) Total Score | The BARS is an instrument that assesses the severity of drug-induced akathisia. The BARS included 3 items for rating objective restless movements, subjective restlessness, and any subjective distress associated with akathisia that were scored on a 4-point scale of 0 (normal) to 3 (most severe) and summed up yielding a total score ranging from 0 (normal) to 9 (most severe). Higher scores indicated greater severity of akathisia. | Safety Analysis Set for Period 1 included all randomized participants who received at least 1 dose of TV-44749 or placebo. Participants were included in the treatment group corresponding to what they actually received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Integrated Study Period: Change From Baseline to Week 60 in BARS Total Score | The BARS is an instrument that assesses the severity of drug-induced akathisia. The BARS included 3 items for rating objective restless movements, subjective restlessness, and any subjective distress associated with akathisia that were scored on a 4-point scale of 0 (normal) to 3 (most severe) and summed up yielding a total score ranging from 0 (normal) to 9 (most severe). Higher scores indicated greater severity of akathisia. | Safety Analysis Set for integrated study period included all participants in the safety analysis set of period 1 that received 1 of the 3 TV-44749 treatments groups and all randomized participants to Period 2 who received at least 1 dose of TV-44749. Participants were included in their randomized treatment groups regardless of the actual treatment received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 60 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Number of Participants With Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent. | Safety Analysis Set for Period 1 included all randomized participants who received at least 1 dose of TV-44749 or placebo. Participants were included in the treatment group corresponding to what they actually received. | Posted | Count of Participants | Participants | Baseline up to Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Integrated Study Period: Number of Participants With Any Suicidal Ideation or Suicidal Behavior According to the C-SSRS | The C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent. | Safety Analysis Set for integrated study period included all participants in the safety analysis set of period 1 that received 1 of the 3 TV-44749 treatments groups and all randomized participants to Period 2 who received at least 1 dose of TV-44749. Participants were included in their randomized treatment groups regardless of the actual treatment received. | Posted | Count of Participants | Participants | Baseline up to Week 60 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Double-blind Period: Change From Baseline to Week 8 in Calgary Depression Scale for Schizophrenia (CDSS) Score | The CDSS is specifically designed to assess the level of depression separate from the positive, negative, and extrapyramidal symptoms in schizophrenia. This clinician-administered instrument consisted of 9 items, each rated on a 4-point scale from 0 (absent) to 3 (severe) that are added together to form the CDSS depression total score for the participant ranging from 0 (absent) to 27 (severe) with higher scores indicating a higher severity of depression. | Safety Analysis Set for Period 1 included all randomized participants who received at least 1 dose of TV-44749 or placebo. Participants were included in the treatment group corresponding to what they actually received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Integrated Study Period: Change From Baseline to Week 60 in CDSS Score | The CDSS is specifically designed to assess the level of depression separate from the positive, negative, and extrapyramidal symptoms in schizophrenia. This clinician-administered instrument consisted of 9 items, each rated on a 4-point scale from 0 (absent) to 3 (severe) that are added together to form the CDSS depression total score for the participant ranging from 0 (absent) to 27 (severe) with higher scores indicating a higher severity of depression. | Safety Analysis Set for integrated study period included all participants in the safety analysis set of period 1 that received 1 of the 3 TV-44749 treatments groups and all randomized participants to Period 2 who received at least 1 dose of TV-44749. Participants were included in their randomized treatment groups regardless of the actual treatment received. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 60 |
|
Double-blind period: Baseline up to Week 8; Integrated study period: Baseline up to Week 60
All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all randomized participants who received at least 1 dose of TV-44749 or placebo.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double Blind Period: Placebo | Participants received placebo matched to TV-44749 SC once monthly over 8 weeks in double-blind period. | 0 | 168 | 3 | 167 | 38 | 167 |
| EG001 | Double Blind Period: TV-44749 318 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 318 mg SC once monthly over 8 weeks in double-blind period. | 0 | 169 | 4 | 163 | 82 | 163 |
| EG002 | Double Blind Period: TV-44749 425 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. | 0 | 169 | 1 | 168 | 99 | 168 |
| EG003 | Double Blind Period: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. | 0 | 169 | 2 | 169 | 98 | 169 |
| EG004 | Integrated Study Period: TV-44749 318 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 318 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. | 2 | 209 | 15 | 204 | 105 | 204 |
| EG005 | Integrated Study Period: TV-44749 425 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. | 0 | 204 | 8 | 203 | 113 | 203 |
| EG006 | Integrated Study Period: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. | 1 | 198 | 13 | 197 | 113 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Shoulder fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alcoholic psychosis | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depressive symptom | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Psychotic symptom | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products R&D LLC | 888-483-8279 | USMedInfo@tevapharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2024 | Dec 17, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Randomized But Not Treated |
|
| Other Than Specified |
|
| >30 - 45 years |
|
| >45 - 65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Not reported |
|
| Other |
|
|
Mixed model for repeated measures fitted to 200 multiply imputed datasets generated in accordance with the estimand. Treatment group LS mean, 95% confidence intervals, and two-sided p values were pooled across imputations using Rubin's rules. |
| Mixed Models Analysis |
| <0.0001 |
p-value was adjusted for multiple comparisons (using Truncated Hochberg). |
| LS Mean Difference |
| -11.27 |
| 2-Sided |
| 95 |
| -15.01 |
| -7.53 |
| Other |
| Mixed model for repeated measures fitted to 200 multiply imputed datasets generated in accordance with the estimand. Treatment group LS mean, 95% confidence intervals, and two-sided p values were pooled across imputations using Rubin's rules. | Mixed Models Analysis | <0.0001 | p-value was adjusted for multiple comparisons (using Truncated Hochberg). | LS Mean Difference | -9.76 | 2-Sided | 95 | -13.50 | -6.02 | Other |
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
|
Participants received TV-44749 extended-release injectable suspension at a dose of 318 mg SC once monthly over 8 weeks in double-blind period. |
| OG002 | Double-blind: TV-44749 425 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
|
| OG002 |
| Double-blind: TV-44749 425 mg |
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks.
| OG002 | Integrated Study Period: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
|
|
Participants received TV-44749 extended-release injectable suspension at a dose of 318 mg SC once monthly over 8 weeks in double-blind period. |
| OG002 | Double-blind: TV-44749 425 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
| OG002 |
| Double-blind: TV-44749 425 mg |
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
| Double-blind: TV-44749 425 mg |
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
Participants received TV-44749 extended-release injectable suspension at a dose of 318 mg SC once monthly over 8 weeks in double-blind period. |
| OG002 | Double-blind: TV-44749 425 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
| Double-blind: TV-44749 425 mg |
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
| OG002 | Integrated Study Period: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
|
|
| OG002 | Double-blind: TV-44749 425 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
| Integrated Study Period: TV-44749 425 mg |
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
| OG002 | Integrated Study Period: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
|
|
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
| OG002 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
|
|
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
| OG002 | Integrated Study Period: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
|
|
| OG002 | Double-blind: TV-44749 425 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
| OG002 | Integrated Study Period: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
|
|
Participants received TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| OG003 | Double-blind: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
|
|
| OG002 | Integrated Study Period: TV-44749 531 mg | Participants received TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period and up to an additional 48 weeks in open-label period, for a total of 56 weeks. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|